Kornimate/medical-research-clean huggingface dataset:
persistence of mr3 in chronic myeloid leukemia (cml) after a 2nd stop of tki treatment

Conditions: CML, Relapsed

Summary: this study will enroll cml patients who have failed a first tki stopping attempt. after failure and at least a year of tki treatment, patients will proceed to dasatinib treatment for another 2 years. if mr4 or better is re-achieved and maintained for at least one year, patients will be eligible for a second stop. after verification of mr4, tki treatment will be stopped and patients followed in the same manner as after first stop. if mmr is lost (bcr-abl \>0.1% (is)), tki treatment will once again be restarted.

the dastop2 study aims to retreat patients who relapse in the euro-ski study (or who stopped tki treatment outside trials but according to euro-ski procedures), with tki for at least another 3 years, out of last two years with dasatinib. if mr4 or better is re-achieved and maintained for at least one year, patients will be eligible for a second stop. after verification of mr4, tki treatment will be stopped and patients followed in the same manner as after first stop. if mmr is lost (bcr-abl \>0.1% (is)), tki treatment will once again be restarted. patients exhibiting hematological relapse after first stop attempt will not be offered a second stop within this study. the same applies to patients in whom tki was restarted prematurely (without loss of mmr).

Eligibility criteria:
inclusion criteria: 1. cml in chronical phase (cp) under tki treatment after failing a prior attempt to stop treatment within euro-ski or outside the study but according to euro-ski trial procedures. for the latter group this requires at least 3 years of tki treatment (first line or second line due to intolerance to first line) before first stop, and mr4 for at least one year before stopping. 2. treated with tki for at least one year after having failed a prior attempt to stop tki. previous tki can be any. 3. typical bcr/abl1 transcript (b3a2 and/or b2a2) must have been confirmed at diagnosis or later during the disease course. 4. 18 years or older. exclusion criteria: 1. previous hematological relapse after first stop of tki. 2. previous ap/bc at any time in the history of the disease. 3. restart of tki without loss of mmr after first stop 4. current participation in another clinical study. 5. previous or planned allogeneic stem cell transplantation. 6. patients with contra-indications to dasatinib therapy due to comorbidities. 7. subjects with acute hepatitis b virus (hbv) infections. 8. uncontrolled or significant cardiovascular disease. 9. pulmonary arterial hypertension. 10. pleural or pericardial effusions of any grade at study entry are excluded 11. history of significant bleeding disorder unrelated to cml 12. hypersensitivity to dasatinib and excipients of dasatinib tablets.

Keywords: cml second stop dasatinib
cd19/70 bi-specific car-t cell therapy

Conditions: B Cell Malignancies

Summary: the purpose of this study is to assess the feasibility, safety and efficacy of cd19/70 bi-specific car-t cell therapy in patients with cd19 and/or cd70 positive b cell malignancies. another goal of the study is to learn more about the safety and function of the anti-cd19/70 bi-specific car-t cells and their persistency in patients.

patients with refractory and/or recurrent b cell malignancies have poor prognosis despite complex multimodal therapy. despite impressive progress, more than 50% of patients treated with cd19-targeting chimeric antigen receptor t cells (car19) experience progressive disease. further, more than 40% patients with progressive large b cell lymphoma (lbcl) experienced reduced or lost expression of cd19 on the tumor cells after car19 treatment; low surface cd19 density before treatment was associated with progressive disease. therefore, novel curative approaches are needed. the investigation attempts to use genetically modified t cells to express a 4th generation lentiviral anti-cd19/70 bi-specific car (bi-4scar-cd19/70). the car molecules enable the t cells to recognize and kill tumor cells through the recognition of a surface antigen, cd19 or cd70, which is expressed at high levels on tumor cells but not at significant levels on normal tissues. cd70 is highly expressed in many cancers, but limited in normal tissues, it is a potential car-t therapeutic target. expression of cd70 was observed on multiple tumor types including solid tumor as well as b cell malignancies. in addition, it has been reported that anti-cd70 car t-cells can eliminate cd70-positive cells and exhibit strong anti-tumor effects in preclinical animal models. the cd70 targeted car-t cells with binding moiety of cd70 specific scfv exhibited a higher affinity and antitumor effect against cd70-positive tumor cells. a potential strategy to prevent relapse due to antigen escape is to infuse t-cells capable of recognizing multiple antigens. to overcome tumor escape of single target antigen and enhance in vivo car-t efficacy, a novel bi-specific cd19/70 car-t therapy regimen is developed to include booster and consolidation car-t applications to target highly-refractory b cell cancer. the aim is to evaluate safety and long term efficacy of the bi-car-t therapy strategy in cd19 and/or cd70 positive cancer patients.

Eligibility criteria:
inclusion criteria: 1. age older than 6 months. 2. malignant b cell surface expression of cd19 or cd70 molecules. 3. the kps score over 80 points, and survival time is more than 1 month. 4. greater than hgb 80 g/l. 5. no contraindications to blood cell collection. exclusion criteria: 1. accompanied with other active diseases and difficult to assess patient response. 2. bacterial, fungal, or viral infection, unable to control. 3. living with hiv. 4. active hbv or hcv infection. 5. pregnant and nursing mothers. 6. under systemic steroid treatment within a week of the treatment. 7. prior failed cd19 and cd70 car-t treatment.

Keywords: car-t b cell malignancies cd19 cd70
diagnostic significance of ctcs in patients with thyroid nodules (circulating tumor cells)

Conditions: Thyroid Nodule; Diagnoses Disease

Summary: thyroid nodule patients with suggestion of fine needle aspiration biopsy (fnab) offered by ultrasound are enrolled in the study. ctcs tested by optimizing method and fnab will be performed simultaneously. this is a double blind trial which pathologists and inspectors of ctcs don't know the result of each other. surgical pathology and diagnostic results of fnab is the primary endpoint and comparison will be made to see if ctcs combined with ultrasound can get similar diagnostic performance as fnab. the diagnostic results of fnab included bethesda class ii and more than v which are defined as benign and malignant, respectively.

some retrospective analysises showed ctcs is considered to be valuable for diagnosis, staging, prognosis and follow-up in several types of cancers and some mrna markers are helpful in differentiating patients with benign versus malignant thyroid disease. however, the lack of sensitivity and specificity of mrna measurements restricted their clinical application. the aim of this study is to see if optimizing test method combined with ultrasound can get similar diagnostic performance. 200 patients with thyroid nodules (≤2cm) which need to undergo fnab will be enrolled in four centers of northern china. patients will simultaneously undergo ctcs tests and fnab. and following treatments will be performed according to the previous standard. allowed by the patients, the investigators will obtain 10ml peripheral blood samples from the participants to make a ctcs test before any fnab. the primary end point is the pathologically confirmed benign versus malignant thyroid disease, which including surgical pathology and diagnostic results of fnab.

Eligibility criteria:
inclusion criteria: * patients with thyroid nodules (≤2cm) untreatment fnab suggested by ultrasound exclusion criteria: * the history of other cancer the history of thyroid surgery bethesda class 3 without surgery

Keywords: fine needle aspiration biopsy circulating tumor cells benign malignant
analysis of the effect oh the carriere motion 3d

Conditions: Angle Class II

Summary: class ii subdivision malocclusions are common and complex to treat due to their asymmetry. the range of orthodontic correction devices is expanding towards systems that are more comfortable for the patient but may not necessarily have scientific evidence to demonstrate their effectiveness. the aim of this study was therefore to evaluate, for the first time, the effect of a class ii correction device, namely the carriere motion 3d (cma), on patients with a class ii subdivision malocclusion. method:this retrospective observational study included all patients presenting with a class ii subdivision malocclusion and treated with cma between july 2018 and november 2023. before treatment (t0) and after treatment with cma (t1), orthodontic data from dental molds and lateral cephalometric radiographs (steiner analysis) were collected and statistically analyzed to assess dentoalveolar as well as skeletal effects of treatment using cma."


Eligibility criteria:
inclusion criteria: * patients who have completed their growth and present with a class ii subdivision malocclusion. * patients who underwent orthodontic treatment with cma between 07/11/2018 and 11/22/2023. * patients who have a complete orthodontic record allowing for pre- and post-treatment measurements with cma. exclusion criteria: none
study of dcr-phxc-101 in normal healthy volunteers and patients with primary hyperoxaluria

Conditions: Primary Hyperoxaluria

Summary: this is a double-blind, placebo-controlled, dose escalation trial of dcr-phxc in healthy volunteers (hvs) and patients with primary hyperoxaluria (ph). once safety has been established in hv, ph patients with a confirmed diagnosis of ph1 and ph2 will be enrolled across multiple dosing cohorts. the study design will allow enrollment of ph patient cohorts at a given dose level once safety has been demonstrated in hv at that dose level. the study will be conducted in two parts: part a: single ascending dose (sad) in hv; part b: sad in patients with ph1 and ph2 (lagging part a by 1 dose level cohort).


Eligibility criteria:
group a (hvs) major inclusion criteria: * willing and able to provide informed consent and comply with study requirements. * male or female subjects between 18 and 55 years of age, inclusive. * subject must have a body mass index (bmi) 19.0 to 32 kg/m2, inclusive. * non-smokers, at least 1-month tobacco free, and willing to remain tobacco free through end of study (eos). * women of child bearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception. group a (hvs) major exclusion criteria: * presence of any medical condition, including but not limited to: severe intercurrent illness, known causes of active liver disease. * routine or chronic use of more than 3 grams of acetaminophen (tylenol) daily. * history of kidney stones. * use of any investigational agent within 90 days before the first dose of study medication. * history of donation of more than 450 ml of blood within 90 days prior to dosing in the clinical research center or planned donation less than 30 days after receiving investigational medicinal product (imp). * plasma or platelet donation within 7 days of dosing and through eos. * history of reactions to an oligonucleotide-based therapy. * males with female partners who are planning to attempt to become pregnant during this study or within 90 days after last dosing of imp. * plasma or platelet donation within 7 days of dosing and through eos. group b (ph1 and ph2 patients) major inclusion criteria: * willing and able to provide informed consent and comply with study requirements. * male or female, at least 6 years of age. * minimum body weight of 25 kg. * genetic confirmation of ph1 and ph2 disease. * meet the 24 hour urine oxalate excretion requirements. * estimated glomerular filtration rate (egfr) ≥30 ml/min/1.73 m2. * if taking vitamin b6 (pyridoxine), must have been on stable regimen for at least 4 weeks. group b (ph1 and ph2 patients) major exclusion criteria: * prior renal and/or hepatic transplantation. * currently receiving dialysis. * participation in any clinical study where they received an investigational agent within 4 months before enrollment. * presence of any medical condition, including but not limited to: severe intercurrent illness, known causes of active liver disease. * liver function test (lft) abnormalities. * history of reactions to an oligonucleotide-based therapy.
study evaluating benefit of using fibrin glue in septorhinoplasty

Conditions: Recovery Time; Bruising

Summary: the purpose of this study is to determine whether the use of fibrin glue during nasal surgery leads to a shorter recovery period with less bruising and/or swelling.

septorhinoplasty is a well established technique to correct nasal deformity. drawbacks of this procedure include a significant recovery following surgery which may often require nasal taping and casting. swelling and bruising in and around the surgical site may persist for months after the operation. at present, there is no standard regarding the length of time nasal tape and cast should be used following septorhinoplasty. it has never been proven that taping or casting is required - in surgeries that require minimal amounts of tissue handling, we may not use any tape or cast following the procedure. homologous fibrin glue has been used for various cosmetic facial plastic procedures since the early 1980's. it has been shown to decrease bruising and swelling following surgery. this study is being undertaken to evaluate these benefits of using fibrin glue in nasal surgery.

Eligibility criteria:
inclusion criteria: * any patient over 18 years of age undergoing septorhinoplasty. exclusion criteria: * any patient having more than one procedure performed during one anesthetic.(i.e.brow lift, face lift, blepharoplasty)

Keywords: nasal surgery septorhinoplasty fibrin glue fibrinogen swelling fibrin tisseel
platelet adhesion in the pathobiology of aortic stenosis

Conditions: Aortic Valve Stenosis

Summary: aortic stenosis (as) is a serious and common condition that affects 2-3% of the population \>65 years of age in western countries. it is also responsible for extraordinarily high healthcare expenditures, estimated to be over $6 billion annually,2 in part because the primary treatment for severe as is aortic valve replacement (avr) which is resource-intensive. valve abnormalities are frequently recognized before as becomes severe, or before there is need for guideline-directed procedural intervention, thereby providing an opportunity for pharmacologic intervention to slow disease progression. yet, all attempts to prevent as progression in those with degenerative non-congenital forms of disease have failed. the only non-procedural intervention that benefits patients with moderate or greater as is the aggressive treatment of hypertension, which reduces net left ventricular (lv) afterload (valvulo-arterial impedance \[zva\]) and can slow secondary lv remodeling. the overall goal of this proposal is to integrate advanced imaging and vascular biology to study how von willebrand factor (vwf) and platelet adhesion promote as progression through many parallel pathways, thereby representing a potential therapeutic target. we are hypothesizing that blood markers of abnormal vwf proteolysis and platelet-derived factors, and abnormal valve shear patterns which can be detected by advanced analysis of spectral doppler on echocardiography are predictors for progressive as.


Eligibility criteria:
inclusion criteria for as group * age \>25 years of age * mild or moderate calcific, non-congenital aortic stenosis by echocardiography within the prior 3 months defined as: * aortic valve area 1.0 cm2 - 1.9 cm2 and either * peak velocity of \>2.5 m/s and \ 25 ml/m2), or * vti ratio (lvot:aov) of \ 0.25 with abnormal stroke volume (\ 60 ml/m2). * age and sex-matched control subjects undergoing echocardiography with no aortic stenosis, and no more than mild severity disease of other valves. inclusion criteria for control group exclusion criteria: -
efficacy and safety of faropenem in bangladeshi adult patients with community-acquired bacterial pneumonia (cabp)

Conditions: Pneumonia, Community-Acquired; Bacterial Pneumonia

Summary: the goal of this clinical trial is to evaluate the efficacy and safety of faropenem in comparison to co-amoxiclav and clarithromycin in bangladeshi adults diagnosed with community-acquired bacterial pneumonia (cabp). eligible participants will be randomly assigned to one of two treatment arms. the first arm will receive faropenem at a dosage of 200 mg administered three times daily for a duration of seven days. the second arm will receive co-amoxiclav 625 mg, also three times daily, along with clarithromycin 500 mg, administered twice daily for seven days. all participants included in the study will undergo follow-up assessments over a period of four weeks. this research aims to provide valuable insights regarding the potential role of faropenem, thereby enhancing clinical outcomes and informing antibiotic stewardship in a region significantly burdened by cabp and characterized by limited treatment alternatives.


Eligibility criteria:
inclusion criteria: * male or female patients aged between 18 to 65 years. * have an acute illness (less than or equal to 7 days duration) with any of the following signs and symptoms consistent with a lower respiratory tract infection (new or worsening): 1. fever (body temperature \> 38.0 °c (100.4 °f) measured orally) 2. shortness of breath 3. new onset or increased cough with or without sputum production. 4. chest pain. * have radiographically documented bacterial pneumonia: 1. infiltrates in a unilateral, lobar distribution 2. diffuse opacities or white condensed area 3. the alveoli fill with white inflammatory fluid exclusion criteria: * patients with severe pneumonia (clinical \& radiological assessment) * patients with suspicion of viral pneumonia (bilateral, patchy opacities, etc., in chest radiography.) * patients with suspicion of nosocomial pneumonia, aspiration pneumonia, etc. * history of hypersensitivity, known or suspected contraindications, or intolerance to any of the study drugs. * intake of an antibiotic within the last 48 hours before study admission. * history of hospitalization within the last 28 days. * patients in pregnancy and lactational state. * patients with renal impairment (screening egfr \< 30ml/min). * significant hepatic impairment (alanine aminotransferase \> three times the upper limit of normal). * serious diseases that affect the immune system, such as acquired immunodeficiency syndrome (aids), cancer, etc. * patients who are taking steroid medications, at least 20 mg daily dose of prednisolone (or equivalent doses of other glucocorticoids). * patients who are accepting chemotherapy or anti-cancer therapy or plan to receive such treatment during the trial or six months prior to enrollment. * had epilepsy, stroke, or other central nervous system disorders or uncontrolled psychiatric history.

Keywords: cabp faropenem
electrical neuromodulation for focal epilepsy

Conditions: Epilepsy

Summary: the purpose of this research is to use electrical neuromodulation on patients with focal epilepsy. the main objective is to assess safety and observe potential therapeutic effects.


Eligibility criteria:
inclusion criteria: part 1 * age ≥ 20 years old. * focal epilepsy patients having received eeg and brain imaging studies and on standard medication. part 2 * age ≥ 20 years old. * focal epilepsy patients having received eeg and brain imaging studies and on standard medication for at least 1 year. * having received part i intervention. exclusion criteria: part 1 * patients with secondary and progressive macrostructural abnormalities in the brain, such as brain tumors or infectious lesions. this does not include abnormalities directly related to epilepsy, such as mesial temporal sclerosis or focal dysplasia. * patients who are unable to undergo brain electrical stimulation, including those with metal in the brain or implanted stimulators/implants. * patients with allergies to the sponge material used for stimulation. * patients with wounds or infections at the site of sponge application. * patients with intellectual disabilities, manic episodes (with a score of greater than 12 on the young mania rating scale), major physiological illnesses (such as stroke, brain tumors, or heart attacks), or pregnant or breastfeeding women. * patients judged by the physician to be unsuitable for the clinical trial due to unstable vital signs or serious internal or external medical conditions. part 2 * patients with secondary and progressive macrostructural abnormalities in the brain, such as brain tumors or infectious lesions. this does not include abnormalities directly related to epilepsy, such as mesial temporal sclerosis or focal dysplasia. * patients who could be considered for single focus resection based on the neurologist/neurosurgeon's judgment. however, patients who clearly refuse resection surgery are not subject to this limitation. * patients who experience serious adverse events (saes) during the part 1 trial. * patients who are unable to undergo magnetic resonance imaging (mri). * patients who are planned to receive hyperthermia therapy or transcranial magnetic stimulation. * patients judged by the physician to be unsuitable for the clinical trial due to unstable vital signs or serious internal or external medical conditions.
clinical trial to evaluate the efficacy and safety of sarpogrelate sr in patients with chronic artery occlusive disease

Conditions: Arterial Occlusive Diseases; Intermittent Claudication

Summary: this clinical trial aims to assess the non-inferiority of sarpogrelate sr 300mg once daily compared to sarpogrelate 100mg three times daily in patients having intermittent claudication among chronic artery occlusive disease, based on changes in the ankle-brachial index (abi).

the clinical trial is a randomized, multicenter, open-label, parallel-group, phase 4 study conducted to evaluate the non-inferiority of sarpogrelate sr 300mg once daily compared to sarpogrelate 100mg three times daily in patients having intermittent claudication among chronic artery occlusive disease. eligible patients who sign the informed consent form voluntarily will receive the investigational products. subsequently, they will undergo observation and various assessments at the 12-week and 24-week visits. the trial is designed to determine whether sarpogrelate sr 300mg once daily is inferior to sarpogrelate 100mg three times daily in terms of changes in the ankle-brachial index (abi).

Eligibility criteria:
inclusion criteria: * male or female adults aged ≥ 19 * diagnosis of chronic arterial occlusive disease * experience of intermittent claudication symptoms for at least 3 months * receiving sarpogrelate for a minimum of 4 weeks prior to the baseline * lower limb pain measured at vas 40mm or higher at baseline exclusion criteria: * patients with coronary artery disease or cerebrovascular disease related to arteriosclerosis undergoing or scheduled for surgery or medication treatment * patients with a history of severe heart failure within the 6 months prior to the screening * patients with a history of bleeding * patients receiving anticoagulants or medications with antiplatelet activity at baseline * patients diagnosed with peripheral neuropathy and currently taking neuropathic pain medications * patients with infectious or progressive fibrotic diseases such as rheumatoid arthritis, systemic lupus erythematosus, idiopathic pulmonary fibrosis, etc

Keywords: sarpogrelate sustained release sarpogrelate